ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee
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Purpose
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.
| Condition | Intervention |
|---|---|
|
Cartilage Defect |
Device: ChonDux |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pivotal Study in Europe for CE Mark |
- Defect fill at 6 months determined by magnetic resonance imaging (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pain score (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Knee function as assessed by the IKDC questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- SF-36 Health Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ChonDux plus microfracture |
Device: ChonDux
Comparison of ChonDux plus microfracture to microfracture only
|
| Active Comparator: Microfracture |
Device: ChonDux
Comparison of ChonDux plus microfracture to microfracture only
Device: ChonDux
single use device
|
Detailed Description:
Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A standing radiograph of the knee showing a Kellgren score of 0-2
- Body mass index ≤33
- An Outerbridge score of III or IV without need for bone graft
- A meniscus with no more than partial resection in the affected knee
Exclusion Criteria:
- Passive motion deficit of the knee (>5º of extension, >15º of flexion)
- Moderate or severe osteoarthritis
- Diabetes mellitus (IDDM Type 1)
- Patellofemoral instability
- Malalignment with > 5° valgus or varus compared to contralateral knee
- Active osteomyelitis
Contacts and Locations| Austria | |
| Medalp | |
| Imst, Austria | |
| Ortho.Abteilung, AKH Linz | |
| Linz, Austria | |
| Germany | |
| Krakenhaus Altentreptow | |
| Altentreptow, Germany | |
| Orthopedic and Pain Center Freiberg | |
| Freiberg, Germany | |
| University Mannheim | |
| Mannheim, Germany | |
| Netherlands | |
| Meander Medical Center | |
| Baarn, Netherlands | |
| Tergooiziekenhuizen | |
| Hilversum, Netherlands | |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01110070 History of Changes |
| Other Study ID Numbers: | CCS-08 |
| Study First Received: | April 22, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Biomet, Inc.:
|
articular cartilage microfracture |
knee pain cartilage repair Subjects with an articular cartilage defect in the knee. |
ClinicalTrials.gov processed this record on May 22, 2013